Biotech/Pharmaceutical

Associate Director Biostatistics, Medical Affairs

Permanent

Penfield Search Partners

Contact: Barbara Day 201.784.9028 bday@penfieldsearch.com

Job Description: The Medical Affairs Biostatistician will be part of a dedicated team within Biometrics & Data Sciences (BDS), providing support to Medical Affairs for one or more compounds within a Therapeutic Area (TA). He/She will be a member of a cross-functional team, contributing to the effective delivery of a very large and diverse book of work, across one or more Company products within a TA and late stage pipeline assets with regards to publication and scientific congress support, non-registrational data generation including Company medical sponsored trials or investigator sponsored trials, data mining for identifying important new opportunities, developing responses to scientific requests for information from health care providers and key opinion leaders. Statisticians develop collaborative relationships and work effectively with the Biometrics & Data Sciences (BDS) Leads, Planning and Execution Lead, Medical Leads, Publication Leads and other members of the study/indication team.

Primary Responsibilities include:

  • Effectively engages as a matrix team member on high level project teams to act as a scientific and strategic partner in the publication strategy and conference support
  • Contributes to the effective delivery of a very large and diverse book of work, across one or more Company compounds within a TA and late stage pipeline assets
  • Independently leads the development and execution of statistical aspects for Company medical sponsored clinical trials, including contribution to study trial design, analysis planning, study results presentation and interpretation, clinical study report authoring and publications.
  • Provides statistical input on investigator sponsored trials
  • Utilizes strong technical skills to address complex issues within a team
  • Demonstrates knowledge outside of traditional statistical expertise in the clinical, medical, and commercial environments
  • Presents summary data and analyses to key stakeholders and review committees in a clear, concise, complete, and transparent manner that provide influence on key development decisions
  • Extensive technical knowledge of statistical methodology that is appropriately applied in trial design and data analysis for clear, concise, high-quality results.
  • Takes accountability for ensuring quality in all planning, design, and execution of assignments
  • Develop less experienced statisticians in the team

Education/Experience:

  • PhD degree in statistics or biostatistics or Masters degree with relevant experience required.
  • >5 years Pharmaceutical/R&D, including supporting Medical Affairs activities
  • Expertise in statistical / clinical trials methodology as it relates to clinical development
  • Capability to solve complex statistical problems
  • Extensive data analysis planning, execution, and delivery experience
  • Excellent verbal and written communications skills.
  • Ability to be flexible and adapt quickly to the changing needs of the organization.
  • Strong interpersonal skills evidenced in interactions with individuals at all levels of the organization and demonstrated ability to develop relationships within the organization and leverage the formal and informal organizational structure to assist in goal achievement.
  • SAS knowledge

Tagged as: Associate Director Biostatistics, Medical Affairs